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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03783403




Registration number
NCT03783403
Ethics application status
Date submitted
19/12/2018
Date registered
21/12/2018
Date last updated
17/02/2021

Titles & IDs
Public title
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPa, in Subjects With Advanced Solid and Hematologic Cancers
Scientific title
A Phase 1, Open-Label, Dose Finding Study of CC-95251, A Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
Secondary ID [1] 0 0
U1111-1224-8251
Secondary ID [2] 0 0
CC-95251-ST-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-95251
Treatment: Drugs - Rituximab
Treatment: Drugs - Cetuximab

Experimental: CC-95251 alone - CC-95251 administered by IV (intravenous) infusion

Experimental: CC-95251 in combination with rituximab - CC-95251 administered by IV (intravenous) infusion; Rituximab administered by IV (intravenous) infusion.

Experimental: CC-95251 in combination with cetuximab - CC-95251 administered by IV (intravenous) infusion; Cetuximab administered by IV (intravenous) infusion.


Treatment: Drugs: CC-95251
CC-95251 administered by IV (intravenous) infusion.

Treatment: Drugs: Rituximab
Rituximab administered by IV (intravenous) infusion.

Treatment: Drugs: Cetuximab
Cetuximab administered by IV (intravenous) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Event(s) - Number of subjects with adverse event
Timepoint [1] 0 0
From enrollment until at least 56 days after completion of study treatment
Primary outcome [2] 0 0
Non-Tolerated Dose (NTD) - A dose that causes unacceptable side effects.
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
Maximum Tolerated Dose (MTD) - The highest dose that does not cause unacceptable side effects.
Timepoint [3] 0 0
18 months
Primary outcome [4] 0 0
Dose-Limiting Toxicity (DLT) - Any adverse events meeting the protocol-defined DLT criteria.
Timepoint [4] 0 0
30 months
Secondary outcome [1] 0 0
Overall response rate (ORR) - The percent of subjects whose best response is CR or PR.
Timepoint [1] 0 0
66 Months
Secondary outcome [2] 0 0
Time to response (TTR) - Time from the first dose to the first objective tumor response observed for patients who achieved a CR or PR.
Timepoint [2] 0 0
66 Months
Secondary outcome [3] 0 0
Duration of response (DOR) - Time from the first objective tumor response observed for patients who achieved a CR or PR until the first date at progressive disease is objectively documented.
Timepoint [3] 0 0
66 Months
Secondary outcome [4] 0 0
Progression free survival (PFS) - Time from the first dose to the first occurrence of disease progression or death from any cause.
Timepoint [4] 0 0
66 Months
Secondary outcome [5] 0 0
Overall survival (OS) - Time from the first dose to death due to any cause.
Timepoint [5] 0 0
66 Months
Secondary outcome [6] 0 0
Pharmacokinetic - Cmax - Maximum serum concentration of the drug
Timepoint [6] 0 0
36 Months
Secondary outcome [7] 0 0
Pharmacokinetic - Cmin - Minimum serum concentration of the drug.
Timepoint [7] 0 0
36 Months
Secondary outcome [8] 0 0
Pharmacokinetic - AUC - Area under the serum concentration time-curve of the drug.
Timepoint [8] 0 0
36 Months
Secondary outcome [9] 0 0
Pharmacokinetic - tmax - Time to peak (maximum) serum concentration of the drug.
Timepoint [9] 0 0
36 Months
Secondary outcome [10] 0 0
Pharmacokinetic - t1/2 - Terminal half-life of the drug.
Timepoint [10] 0 0
36 Months
Secondary outcome [11] 0 0
Pharmacokinetic - CL - Total body clearance of the drug from the serum.
Timepoint [11] 0 0
36 Months
Secondary outcome [12] 0 0
Pharmacokinetic - Vss - Volume of distribution of the drug at steady state.
Timepoint [12] 0 0
36 Months
Secondary outcome [13] 0 0
Anti-CC-95251 antibody (ADA) assessment - Determine the presence and frequency of anti-drug antibodies of the drug.
Timepoint [13] 0 0
36 Months

Eligibility
Key inclusion criteria
1. Subject must understand and voluntarily sign an informed consent form (ICF).

2. Subject (male or female) is = 18 years of age at the time of signing the ICF.

3. Subject must have progressed on (or not been able to tolerate due to medical
comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no
other approved conventional therapy exists and have histological or cytological
confirmation of advanced unresectable solid tumors.

4. Subject must have at least one site of measurable disease as determined by RECIST
v1.1. NHL subjects must have bi-dimensionally measurable disease on cross sectional
imaging by CT or MRI as defined by Lugano/IWG criteria.

5. Subject has an ECOG PS of 0 or 1.

6. Subjects must exhibit acceptable hematopoietic, liver, renal, and coagulation function
as assessed by laboratory tests.

7. Subject is willing and able to adhere to the study visit schedule and other protocol
requirements.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has received prior investigational therapy directed at CD47 or SIRPa.

2. Subject has cancer with symptomatic central nervous system involvement.

3. Subject is on chronic systemic immunosuppressive therapy or corticosteroids.

4. Subjects with a history of clinically significant cardiac disease within the previous
6 months.

5. Subject had a prior systemic cancer-directed treatments or investigational modalities
= 5 half-lives or 4 weeks prior to starting CC-95251, whichever is shorter.

6. Subject had major surgery = 2 weeks prior to starting CC-95251.

7. Subject is a pregnant or lactating female.

8. Subject has known human immunodeficiency virus (HIV) infection.

9. Subject has known chronic, active hepatitis B or C (HBV/HCV) infection.

10. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.

11. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.

12. History of concurrent second cancers requiring active, ongoing systemic treatment.

13. For subjects receiving cetuximab, known history of cetuximab intolerance.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/11/2024
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion
(Parts B and C), first-in-human clinical study of CC-95251 in subjects with advanced cancers.
Trial website
https://clinicaltrials.gov/show/NCT03783403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amar Patel, MD
Address 0 0
Celgene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shailaja Uttamsingh
Address 0 0
Country 0 0
Phone 0 0
415-839-7053
Fax 0 0
Email 0 0
suttamsingh@celgene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03783403